NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY

NCT ID: NCT04706884

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-01

Brief Summary

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Objective: The objective of the study was to investigate a reverse correlation between blood lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

Detailed Description

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The objective of the prospective study was to investigate a reverse correlation between blood lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

Sixty American Society of Anesthesiologists (ASA) II-III patients were included in this study. Perioperative data, including age, weight, body surface area, gender, body temperature, preoperative co-morbidities, intraoperative and postoperative hemodynamic parameters, arterial blood gas analysis (ABG), cardiopulmonary bypass and aortic cross-clamp duration, flow rate, urine output, and blood product and inotropic agent usage, were recorded. Postoperative plasma lactate levels were measured simultaneously with cerebral tissue oxygen saturation (rSO2) in both cerebral hemispheres at 10 different time points.

Conditions

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Etiology of Hyperlactathemia Early Period After Cardiopulmonary Bypass Surgery Washout Phenomenon

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Near infrared spectroscopy

The rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA) II-III patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting

Exclusion Criteria

* Active congestive cardiac failure, intraoperative death, urgent cardiac surgery or reoperation, hemodynamic instability or need of inotropic support before the operation, the elevation of any parameters preoperatively suggestive of systemic hypoperfusion, coagulopathy, renal failure, hepatic dysfunction, local or systemic infection, and inflammation.
Minimum Eligible Age

43 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Sevket Gorgulu

Head of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fevzi Toraman, Prof

Role: STUDY_CHAIR

Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation

Locations

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Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Istanbul, Atakent, Turkey (Türkiye)

Site Status

Acibadem University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ATADEK 2018-2/21

Identifier Type: -

Identifier Source: org_study_id

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